BOSTON--(BUSINESS WIRE)--OncoPep,
Inc. today announced the initiation of a Phase 1b clinical trial
evaluating its investigational vaccine product PVX-410 for the treatment
of patients with metastatic triple negative breast cancer (TNBC) who are
human leukocyte antigen A2 positive (HLA-A2+). The
investigator-sponsored study led by Steven Isakoff, M.D., Ph.D., at
Massachusetts General Hospital, will assess the safety, tolerability and
immune response to PVX-410 alone and in combination with the checkpoint
inhibitor pembrolizumab (Keytruda®, Merck, Inc.). PVX-410 is a
multi-peptide investigational therapeutic cancer vaccine which may act
to help stimulate an immune response against cancer cells.

“This study will help determine if PVX-410 and pembrolizumab
administered together can help the body's immune system to recognize and
potentially reduce or stabilize tumors in patients with metastatic
triple negative breast cancer,” said Dr. Isakoff, Associate Director for
Breast Cancer Clinical Research at the Massachusetts General Hospital
Cancer Center and Assistant Professor in Medicine at Harvard Medical
School. “TNBC continues to be a disease with poor prognosis that
disproportionally affects premenopausal women and African-American women
and new treatment options beyond chemotherapy are desperately needed. I
am pleased to be involved with this research initiative and look forward
to assessing PVX-410 in this unique combination."

The open label, multi-center Phase 1b study is designed to evaluate the
safety and immune response to PVX-410 alone and in combination with
pembrolizumab in HLA-A2+ patients with metastatic TNBC. Patients will
receive weekly injections of PVX-410 for six consecutive weeks, followed
by booster PVX-410 vaccine doses at Week 10 and Week 28. Pembrolizumab
will be administered every three weeks intravenously starting with Week
1. The trial is expected to enroll a total of approximately 20 patients
at multiple trial sites, including Massachusetts General Hospital, Beth
Israel Deaconess Medical Center and the Dana Farber Cancer Institute.
More information on the trial can be found at clinicaltrials.gov,
identifier number NCT03362060.

"OncoPep is now advancing multiple clinical studies of its
investigational vaccine product PVX-410 as a stand-alone and combination
treatment, including this new study with pembrolizumab in metastatic
triple negative breast cancer and an on-going investigator-sponsored
study in combination with durvalumab (Infinzi®,
MedImmune/AstraZeneca), an antibody against the PD-L1 ligand, in the
adjuvant setting for patients with stage II or stage III triple negative
breast cancer,” said Doris Peterkin, Chief Executive Officer of OncoPep.
“We are thrilled with the progress of our cancer immunotherapy program
and the initiation of this Phase 1b investigator sponsored clinical
trial in metastatic triple negative breast cancer and to be working with
Dr. Isakoff’s team.” More information on the adjuvant TNBC trial of
PVX-410 in combination with durvalumab can be found at
clinicaltrials.gov, identifier number NCT02826434.

About Triple Negative Breast CancerTriple negative breast
cancer (TNBC) is a form of breast cancer that lacks the three receptors
found most commonly on breast cancer cells: estrogen receptor (ER),
progesterone receptor (PR), and hormone epidermal growth factor receptor
2 (HER-2). TNBC accounts for approximately 15-20% of all breast cancer
cases and is more likely to spread and recur than other forms of breast
cancer. TNBC disproportionally affects premenopausal women and
African-American women. Patients diagnosed with metastatic TNBC have a
median survival of just over 1 year, and patients with early stage TNBC
have a median 5-year survival of 77% compared to 93% for non-TNBC.
Residual disease after neoadjuvant chemotherapy (non-pathologic complete
response) predicts a poor prognosis with nearly half of such patients
experiencing a recurrence within 5 years.

About PVX-410PVX-410 is a novel investigational therapeutic
cancer vaccine currently in Phase 1b clinical trials in smoldering
multiple myeloma and triple negative breast cancer. PVX-410 consists of
four peptides from unique regions of three tumor -associated antigens
which may act to help stimulate an immune response to the targeted tumor
cell. PVX-410 was granted orphan drug designation from the U.S. Food and
Drug Administration in 2013 for the treatment of multiple myeloma.

About OncoPepOncoPep is developing targeted
immunotherapeutics to prevent the progression of cancer, prolong
survival and restore the quality of life of patients. OncoPep’ s lead
program is an investigational, multi-peptide therapeutic vaccine being
evaluated in treating smoldering multiple myeloma. www.oncopep.com